Expired Study
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Baltimore, Maryland 21224


Purpose:

The purpose of this study is to compare the presence, degree, time course and profile of opioid withdrawal symptoms associated with induction onto new formulations of buprenorphine or buprenorphine/naloxone in persons with active opioid dependence. The primary outcome measure is the severity of withdrawal symptoms measured using the Clinical Opiate Withdrawal Scale. The primary study hypothesis is that neither drug formulation will precipitate an opioid withdrawal syndrome.


Criteria:

Inclusion Criteria: Subject must: - Provide written informed consent. - Have a DSM-IV diagnosis of opioid dependence. - Be male or female, 18 to 65 years of age, inclusive. - If female, have a negative pregnancy test during screening and agree to use an acceptable method of birth control. Exclusion Criteria: Subjects must not: - Have participated in an experimental drug or device study within the last 30 days. - Be currently (past 30 days from start of screening) engaged in opioid agonist, opioid partial agonist, or opioid antagonist treatment. - If female, be breast feeding or lactating. - Have any medical condition that in the opinion of the physician investigator would preclude the subject from completing the study. - Have any clinically significant non-substance use psychiatric disorder (e.g., schizophrenia). - Have current suicidal ideation. - Have a Mini Mental Status Exam score less than 24. - Have physical dependence on alcohol. - Have physical dependence on sedative-hypnotics. - Have active aphthous stomatitis. - Have active oral herpes. - Need on-going prescription medications that interact with the P450 3A4 system.


NCT ID:

NCT00637000


Primary Contact:

Principal Investigator
Eric C. Strain, M.D.
Johns Hopkins University


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21224
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 20, 2018

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